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JP Ventures LLC dba iVape manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization from the FDA, violating the Family Smoking Prevention and Tobacco Control Act. The company's e-liquid products, which were deemed tobacco products effective August 8, 2016, failed to comply with FD&C Act requirements that newly marketed tobacco products obtain premarket approval before commercial distribution in the United States. As the letter excerpt indicates, the products were adulterated and misbranded under federal tobacco product regulations.